NCT00596596

Trial to Evaluate the Efficacy and Safety of R093877 in Patients With Chronic Idiopathic Constipation

A Double-Blind, Placebo-Controlled, Dose-Finding Trial to Evaluate the Efficacy and Safety of Prucalopride (R093877) in Subjects With Chronic Idiopathic Constipation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 313 (actual)
• Sponsor: Movetis · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine whether prucalopride is safe and effective in patients with chronic idiopathic constipation. Hypothesis: At all doses administered prucalopride given once daily for 4 weeks is safe and well tolerated in patients with chronic idiopathic constipation.

Detailed description

This was a double-blind, placebo-controlled, randomized, parallel group, multicentre, Phase II, dose comparison trial, in which 313 subjects, with a history of chronic idiopathic constipation were enrolled. The trial was conducted in three phases: 1. a 4-week drug-free run-in phase, 2. a 4-week double-blind (DB) phase during which subjects were treated with R093877 (0.5 mg, 1 mg, 2 mg, or 4 mg capsule) or matching placebo once daily, prior to breakfast, 3. a 4-week drug-free run-out phase (RO). To qualify for the run-in phase (Visit 1, Week 1) subjects had to have experienced, for at least 3 months, 2 or less spontaneous, bowel movements (SBM)/week with the occurrence of lumpy (scyballae) and/or hard stools, a sensation of incomplete evacuation for at least a quarter of their stools, or straining during defecation at least a quarter of the time.

Conditions

• Constipation

Interventions

Type	Name	Description
DRUG	prucalopride	0,5 mg once daily
DRUG	prucalopride	1 mg once daily
DRUG	2 mg prucalopride	2 mg once daily
DRUG	4 mg prucalopride	4 mg once daily
OTHER	Placebo	placebo once daily

Timeline

• Start date: 1996-09-01
• Primary completion: 1997-06-01
• Completion: 1997-06-01
• First posted: 2008-01-17
• Last updated: 2008-05-29